Top 10 Reasons that IACUC Submissions are Not Approved

The IACUC protocol is the written document
that confirms UCI's adherence to federal animal welfare regulations and ethical
guidelines in the use of live animals for research, testing or teaching. The
committee reviews each protocol to assure that all procedures are adequately
described and appropriately documented.

Even if something is obvious to the
researcher, IT HAS TO BE WRITTEN IN THE PROTOCOL. Listed below are some of the
most common areas where protocol documentation tends to fall short of IACUC
expectations and requirements:

Not enough information: The protocol does not clearly express either
the rationale behind the experiments or the justification for the use of live
animals. Be sure to review all sections
of the protocol narrative application and provide ALL requested information.

Too much information (in the wrong
place): The Experimental Design section must
provide an overview of the project as a whole, including the rationale for the
experiments, a summary of the experimental groups and what procedures will be
performed on them, and the timeline for those procedures (when they are
performed in relation to other procedures and to the endpoint of the
experiment). Details about the procedures
themselves do not belong in the Experimental Design section, but it should be
clear exactly what will happen to each of the animals and why.

The Project Overview is too
technical: The Project Overview is meant
to be a lay summary of the project
as a whole. It should be clearly
understandable to people with little or no background or experience in your
area of expertise. Leave out the jargon
and technical terms, and provide an explanation of what you plan to do that is
suitable for a newspaper article or non-scientific cocktail party chatter.

The consideration of alternatives to the
use of live animals has not been documented:
The IACUC understands that review of the scientific literature is an
ongoing part of the research process; however, it must be documented in the
protocol in order to meet the requirements of USDA Animal Care Policy #12. The IACUC Protocol Application form has been
specifically designed to guide researchers in appropriately documenting the
consideration of alternatives.

Animal numbers are not adequately
justified: The number of animals
requested for the experiments must be adequate to achieve the research goals of
the study – researchers must provide an explanation for how the number of
animals was determined. Wherever
possible, statistical power analysis should be employed.

Inconsistencies in the narrative: All sections of the protocol narrative must
be consistent – procedures and agents mentioned in the Experimental Design must
be described in detail in the appropriate sections of the protocol narrative;
animal numbers and pain categories must be consistent throughout the protocol,
etc.

Animal Welfare Issues: If an equivalent
procedure is reasonably expected to cause pain, distress or discomfort in a
human being, you MUST assume that it would also cause pain, distress or
discomfort in an animal and address these issues accordingly in the protocol
narrative. Monitoring and assessment
parameters must be described in detail, and relief from potential pain and
distress must be provided unless there is a strong scientific justification for
withholding it.

Appendices are not optional: All required appendices must accompany the
protocol narrative submission, as determined in the Application section of the
protocol forms.

ALL three-year de-novo
renewal submissions must include Appendix A – Progress Report

The use of hazardous
agents may also require Standard Operating Procedures and door signage, which
must be submitted as “Appendix C”.

Modification Mishap #1 - Wrong version of
the protocol: IACUC policy requires that
the protocol narrative be updated with each approved modification; it is the
responsibility of the research team to ensure that the most recent version of
the approved protocol narrative is used each time a modification is
submitted. If you recently submitted a
modification request that has not yet been approved, it is best to wait until
that approval is processed before submitting another one. If it is not possible to wait until the
previous mod is approved, contact us at IACUC@uci.edu for advice on
how to proceed.

Modification Mishap #2 - Mod doesn’t fit in with
the existing approved narrative:
Proposed changes that significantly alter the originally approved
protocol may be more appropriately submitted as a new stand-alone
protocol.